Diagnostic Kit SARS-cCo V Antigen Rapid Test
USA Medical
Class I - Dangerous
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Shanghai United Imaging Healthcare Co.
Class I - Dangerous
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
Accula SARS-CoV-2 Test, REF: COV4100
MESA BIOTECH
Class I - Dangerous
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Siemens Healthcare Diagnostics
Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Siemens Healthcare Diagnostics
Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Siemens Healthcare Diagnostics
Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Olympus Corporation of the Americas
Class I - Dangerous
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Siemens Healthcare Diagnostics
Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
SML Distribution
Class I - Dangerous
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
Siemens Healthcare Diagnostics
Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Siemens Healthcare Diagnostics
Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Class I - Dangerous
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Draegar Medical Systems
Class I - Dangerous
Software issue resulting in temporary loss of central monitoring functionality.
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Siemens Healthcare Diagnostics
Class I - Dangerous
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Siemens Medical Solutions USA
Class I - Dangerous
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Siemens Medical Solutions USA
Class I - Dangerous
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Siemens Medical Solutions USA
Class I - Dangerous
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Siemens Medical Solutions USA
Class I - Dangerous
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Matrix Clinical Solution At-Home COVID-19 Test
Matrix Medical Network
Class I - Dangerous
Due to COVID-19 Test not being authorized for home sample collection.